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Virtual reality-based relaxation for enhancement of perioperative well-being and quality of life: protocol for a randomised pilot trial
INTRODUCTION: Patients with cancer undergoing surgery often suffer from reduced quality of life and various forms of distress. Untreated distress can negatively affect coping resources as well as surgical and oncological outcomes. A virtual reality-based stress reduction intervention may increase qu...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8031039/ https://www.ncbi.nlm.nih.gov/pubmed/33827835 http://dx.doi.org/10.1136/bmjopen-2020-044193 |
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author | Schrempf, Matthias Christian Petzold, Julian Quirin Vachon, Hugo Petersen, Morten Aagaard Gutschon, Johanna Wolf, Sebastian Sommer, Florian Murnauer, Marcus Anthuber, Matthias |
author_facet | Schrempf, Matthias Christian Petzold, Julian Quirin Vachon, Hugo Petersen, Morten Aagaard Gutschon, Johanna Wolf, Sebastian Sommer, Florian Murnauer, Marcus Anthuber, Matthias |
author_sort | Schrempf, Matthias Christian |
collection | PubMed |
description | INTRODUCTION: Patients with cancer undergoing surgery often suffer from reduced quality of life and various forms of distress. Untreated distress can negatively affect coping resources as well as surgical and oncological outcomes. A virtual reality-based stress reduction intervention may increase quality of life and well-being and reduce distress in the perioperative phase for patients with cancer. This pilot trial aims to explore the feasibility of the proposed intervention, assess patient acceptability and obtain estimates of effect to provide data for sample size calculations. METHODS AND ANALYSIS: Patients with colorectal cancer and liver metastasis undergoing elective surgery will be recruited for this single-centre, randomised pilot trial with a three-arm design. A total of 54 participants will be randomised at 1:1:1 ratio to one of two intervention groups or a control receiving standard treatment. Those randomised to an intervention group will either receive perioperative virtual reality-based stress reduction exercises twice daily or listen to classical music twice daily. Primary feasibility outcomes are number and proportions of participants recruited, screened, consented and randomised. Furthermore, adherence to the intervention, compliance with the completion of the quality of life questionnaires and feasibility of implementing the trial procedures will be assessed. Secondary clinical outcomes are measurements of the effectiveness of the interventions to inform sample size calculations. ETHICS AND DISSEMINATION: The study protocol, the patient information and the informed consent form have been approved by the ethics committee of the Ludwigs-Maximilians-University, Munich, Germany (Reference Number: 19–915). Study findings will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00020909. |
format | Online Article Text |
id | pubmed-8031039 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-80310392021-04-27 Virtual reality-based relaxation for enhancement of perioperative well-being and quality of life: protocol for a randomised pilot trial Schrempf, Matthias Christian Petzold, Julian Quirin Vachon, Hugo Petersen, Morten Aagaard Gutschon, Johanna Wolf, Sebastian Sommer, Florian Murnauer, Marcus Anthuber, Matthias BMJ Open Surgery INTRODUCTION: Patients with cancer undergoing surgery often suffer from reduced quality of life and various forms of distress. Untreated distress can negatively affect coping resources as well as surgical and oncological outcomes. A virtual reality-based stress reduction intervention may increase quality of life and well-being and reduce distress in the perioperative phase for patients with cancer. This pilot trial aims to explore the feasibility of the proposed intervention, assess patient acceptability and obtain estimates of effect to provide data for sample size calculations. METHODS AND ANALYSIS: Patients with colorectal cancer and liver metastasis undergoing elective surgery will be recruited for this single-centre, randomised pilot trial with a three-arm design. A total of 54 participants will be randomised at 1:1:1 ratio to one of two intervention groups or a control receiving standard treatment. Those randomised to an intervention group will either receive perioperative virtual reality-based stress reduction exercises twice daily or listen to classical music twice daily. Primary feasibility outcomes are number and proportions of participants recruited, screened, consented and randomised. Furthermore, adherence to the intervention, compliance with the completion of the quality of life questionnaires and feasibility of implementing the trial procedures will be assessed. Secondary clinical outcomes are measurements of the effectiveness of the interventions to inform sample size calculations. ETHICS AND DISSEMINATION: The study protocol, the patient information and the informed consent form have been approved by the ethics committee of the Ludwigs-Maximilians-University, Munich, Germany (Reference Number: 19–915). Study findings will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00020909. BMJ Publishing Group 2021-04-07 /pmc/articles/PMC8031039/ /pubmed/33827835 http://dx.doi.org/10.1136/bmjopen-2020-044193 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Surgery Schrempf, Matthias Christian Petzold, Julian Quirin Vachon, Hugo Petersen, Morten Aagaard Gutschon, Johanna Wolf, Sebastian Sommer, Florian Murnauer, Marcus Anthuber, Matthias Virtual reality-based relaxation for enhancement of perioperative well-being and quality of life: protocol for a randomised pilot trial |
title | Virtual reality-based relaxation for enhancement of perioperative well-being and quality of life: protocol for a randomised pilot trial |
title_full | Virtual reality-based relaxation for enhancement of perioperative well-being and quality of life: protocol for a randomised pilot trial |
title_fullStr | Virtual reality-based relaxation for enhancement of perioperative well-being and quality of life: protocol for a randomised pilot trial |
title_full_unstemmed | Virtual reality-based relaxation for enhancement of perioperative well-being and quality of life: protocol for a randomised pilot trial |
title_short | Virtual reality-based relaxation for enhancement of perioperative well-being and quality of life: protocol for a randomised pilot trial |
title_sort | virtual reality-based relaxation for enhancement of perioperative well-being and quality of life: protocol for a randomised pilot trial |
topic | Surgery |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8031039/ https://www.ncbi.nlm.nih.gov/pubmed/33827835 http://dx.doi.org/10.1136/bmjopen-2020-044193 |
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